FDA Accepts Merck And Sanofi's BLA For Hexavalent Vaccine
Merck, together with its partner Sanofi Pasteur, the vaccines division of Sanofi, reported that the U.S. Food and Drug Administration (FDA) has accepted for review the companies’ Biologics License Application (BLA) for the investigational pediatric hexavalent vaccine, DTaP5-IPV-Hib-HepB1.
The hexavalent vaccine is a pediatric combination vaccine designed to protect against six diseases. These diseases include diphtheria, hepatitis B, tetanus, pertussis or whooping cough, polio (poliovirus types 1, 2, and 3), and invasive disease caused by Haemophilus influenzae type b (Hib). The vaccine comprises antigens for diphtheria, tetanus, whooping cough, and polio from Sanofi Pasteur, as well as antigens for hepatitis B from Merck. If approved, it would be the first hexavalent vaccine to offer immunity against the six diseases in the U.S.
“Leading organizations – the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians – generally recommend the use of combination vaccines instead of individual injections,” said Dr. John Shiver, SVP of R&D at Sanofi Pasteur.
The application was supported by data from a Phase 3 study investigating the safety and immunogenicity of the pediatric hexavalent vaccine against licensed comparator vaccines. The study involved 1,400 infants who were given the vaccine at the ages of two, four, and six months. Results showed that those who were given the pediatric hexavalent vaccine had non-inferior antibody levels to those who were given comparator vaccines, namely Sanofi Pasteur’s Pentacel 2 plus Merck’s Recombivax HB 3.
“We are excited about reaching another key milestone in the development of this investigational pediatric vaccine against six important diseases,” said Robin Isaacs, VP of Vaccine Clinical Research at Merck Vaccines.
Earlier this year Sanofi Pasteur reported that its pediatric pentavalent vaccine Shan5 has been awarded prequalification status by the World Health Organization (WHO). The vaccine was designed to protect against diphtheria, tetanus, pertussis, Hib, and hepatitis B. The pentavalent vaccine was co-developed with Sanofi Pasteur’s Shantha Biotechnics in Hyderabad, India.